FDA Cracks Down on 'Latex-Free' Claims

WASHINGTON -- The claim "latex-free" is impossible to guarantee and should not be used on labeling of medical products, according to new guidance from the U.S. Food and Drug Administration.

"FDA is aware of no test method or combination of test methods available at this time that can demonstrate the absence of proteins or components from natural rubber latex that may cause allergic reactions in susceptible individuals," the agency said.

The FDA pointed to three tests that detect compounds related to natural rubber latex allergies, two of which meet FDA standards: ASTM D5712, which analyzes aqueous extractable protein in natural rubber, and ASTM D6499, which measures antigenic protein. ASTM D7427, which detects four principal allergenic proteins, has not been recognized by FDA as a standard yet, the agency said.

At least 13 natural rubber latex allergens have been identified, far more than can be detected in the FDA-recognized tests, the agency said.

The FDA recognizes "that the complete absence of all natural rubber latex allergens is unlikely to be necessary for the safe use of medical products by individuals with natural rubber latex allergies," it said. But existing measurements lack the specificity and sensitivity to declare a product completely free of natural rubber latex proteins or antigens, the guidance said.

No regulations mandate the labeling of medical or other products regarding natural rubber latex, the guidance explained. Manufacturers have used the terms "latex-free" or "does not contain latex" to indicate a lack of natural rubber latex, dry natural rubber, or synthetic rubber latex, it said.

"FDA believes that these labeling statements are not sufficiently specific, not necessarily scientifically accurate, and may be misunderstood or applied too widely, and therefore, it is inappropriate to include such statements in medical product labeling," it said.

The guidance covers all FDA-regulated medical products in which natural or synthetic rubber latex were not used as materials in their manufacture, and any packaging or container not made with natural or synthetic rubber latex. The guidance offers recommendations to manufacturers, such as using labels stating that natural and synthetic rubber latex was not used during manufacturing.

An allergic reaction to natural latex rubber can range from dermatitis to anaphylaxis, according to the CDC. That agency currently recommends powder-free gloves for medical and dental professionals because latex in the powder attaches the allergen to the skin. Dental healthcare personnel can be sensitized to latex proteins after repeated exposure, it warned.

Latex allergies usually but not exclusively happen to people after repeat contact with rubber proteins. Glove use among healthcare professionals increased dramatically in the 1990s to guard against infection and communicable disease. Up to 12 percent of healthcare workers and up to 6 percent of the general population may have a latex allergy or sensitivity, reported Daniel Pendick, executive editor of Harvard Men's Health Watch.